Earnings Call Transcript - RLMD Q1 2026

Operator, Operator

Good afternoon, and welcome to Relmada Therapeutics First Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Brian Ritchie, Moderator - LifeSci Advisors / Investor Relations

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the three months ended March 31, 2026. Please note that certain information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during today's call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the Form 10-Q filing for the quarter ended 03/31/2026, filed after the close today. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on 05/12/2026. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj S. Pruthi, Relmada's CMO Urology, who will provide an NDV-01 program update; and Relmada's CFO, Maged S. Shenouda, who will provide an update on cipranolone and a review of the company's Q1 financial results. After that, we will open the line for a brief Q&A session. Now I would like to hand the call over to Sergio Traversa. Sergio?

Sergio Traversa, CEO

Thank you, Brian. Good afternoon, and welcome, everyone, to the Relmada First Quarter 2026 Conference Call. Relmada continues to make excellent progress this year and we are excited about where we stand. The robust 12-month data for NDV-01 in non-muscle invasive bladder cancer, or NMIBC, and the successful completion of a $160 million private placement financing are meaningful milestones that reflect the strengths of our progress. Importantly, we remain on track to initiate the Phase 3 rescue program in mid-2026, which we believe will be a transformational moment for Relmada. Let me briefly describe what makes NDV-01 distinct. NDV-01 is a ready-to-use sustained-release intravesical formulation for gemcitabine and docetaxel, or Gemdosi. It is designed to build on the well-established safety profile of conventional Gemdosi and deliver a best-in-class therapy for patients living with NMIBC. We remain focused on maximizing its potential for success for patients, their urology community, and our investors. Let me walk you through four milestones and speak to the momentum we have built this year. Number one, we have continued to de-risk the development of NDV-01 with the report of solid and durable 12-month efficacy data from the ongoing Phase 2 study of NDV-01. We will be presenting this data and an overview of the Phase 3 rescue program at the American Urological Association 2026 Annual Meeting later this week. High response rates, a favorable safety profile, and ease of use continue to strengthen our conviction that NDV-01 has the potential to provide urologists and patients with NMIBC what they need: a simple, durably effective treatment that readily fits into real-world practice settings. Number two, we achieved FDA alignment for our planned registration of the Phase 3 rescue programs. Number three, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings and have a term into 2047. Lastly, we have fortified our balance sheet. With the private financing that was completed in March, we have the resources to support completion of the Phase 3 rescue program. Before I hand the call to Raj, I want to underscore the significance of the patent filing. The provisional application is directed to both the formulations and method of treatment, reflecting the breadth and novelty of the NDV-01 platform. If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection. Most importantly, it would meaningfully extend the covered claims of NDV-01 into 2047, providing a nine-year extension of commercial exclusivity and strengthening our competitive position as we advance our registration. Looking ahead, as we enter 2026, our focus is on execution. We remain on track to initiate the registration Phase 3 rescue program for NDV-01 in mid-2026. We are also preparing to initiate a proof-of-concept study for cipranolone in Prader-Willi syndrome, targeted for mid-2026. Maged will speak about it in more detail shortly. Next, I will turn the call over to Dr. Raj, who will provide a review of the NDV-01 program, including 12-month follow-up data from the ongoing Phase 2 study and a summary of our Phase 3 plans. Raj?

Raj S. Pruthi, MD, CMO, Urology

Thank you, Sergio, and good afternoon, everyone. I am delighted to provide an update on NDV-01 and our upcoming presentations at the AUA meeting this coming weekend. The AUA is an important platform for us as we look forward to introducing NDV-01 to the broader urology community, building awareness of NDV-01 as a differentiated sustained-release Gemdosi and generating investigator interest in the Phase 3 rescue program. Bladder cancer is one of the most common cancers we see, and its impact on patients is significant. Most are diagnosed in their mid-70s. The disease often comes with high recurrence rates and intensive treatments that can greatly affect quality of life during a stage of life when preserving it is especially important. I want to touch on three topics during today's call. First, a recap of the NDV-01 12-month data. Second, a summary of our planned Phase III program. And third, a discussion of how NDV-01 might fit in the real-world practice of a urologist. As Sergio noted, NDV-01 is a novel sustained-release intravesical formulation of gemcitabine and docetaxel. It builds on physicians' established familiarity with conventional Gemdosi. This is particularly meaningful for patients who are unresponsive to BCG, where bladder-sparing options that avoid radical cystectomy can be life-changing. Turning to the 12-month data: NDV-01 has demonstrated high response rates and durability in our ongoing Phase II study. We believe these results compare favorably to other programs in this space and support NDV-01's potential as a best-in-class treatment for patients with bladder cancer if approved. The Phase 2 study is an open-label, single-arm trial in patients with high-risk NMIBC. Patients received six biweekly doses (that is, every other week), followed by monthly maintenance for up to one year. Regular assessments include cystoscopy, cytology, and biopsy if needed. The study was designed to enroll up to 70 patients. Primary endpoints are safety and complete response rate at 12 months. The data demonstrated a 95% complete response rate at any time and a durable 76% complete response at 12 months in the high-risk NMIBC patients, and a 94% complete response at any time and a durable 80% complete response rate at 12 months in the difficult-to-treat BCG-unresponsive subpopulation, reinforcing its best-in-class potential in NMIBC. No patients had progression to muscle-invasive disease and no patients underwent a radical cystectomy. On the strength of these findings, we are advancing NDV-01 into a Phase III rescue registrational program. The program will evaluate NDV-01 in both second-line BCG-unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following transurethral resection of bladder tumor, or TURBT. We will be presenting the 12-month data at the AUA annual meeting this Friday. We believe these data are compelling and look forward to the discussion they will generate in the urology community. Given the burdensome nature of the existing bladder cancer therapies, safety remains a critical aspect of the therapy's overall profile. We continue to be encouraged by the favorable safety profile observed for NDV-01 in our clinical program. In the 12-month data set, no patients experienced a grade 3 or higher treatment-related adverse event. There were no dose interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade 1. Now turning to the Phase 3 rescue program: we designed the program with two separate approval pathways to increase the likelihood of success while creating the most streamlined route to regulatory approval. We expect to file the U.S. IND and initiate the rescue program across an estimated 80 sites in North America in mid-2026. The rescue program will also be highlighted in the trials and progress session at the AUA annual meeting on Sunday, May 17th, providing an important opportunity to engage the urology community. Let me now walk you through each of the two studies that form the rescue program. Registrational pathway one focuses on patients in the second-line setting — patients who are BCG-unresponsive with carcinoma in situ, or CIS, and refractory to first-line therapies that are approved or in development. We estimate approximately 5,000 patients per year in the U.S. fall into this setting. With few effective alternatives to radical cystectomy, this study is designed as a single-arm trial. The primary endpoint is complete response rate at any time. Secondary endpoints include duration of response, progression-free survival, and recurrence-free survival. We expect to report the first three-month response data around year-end. This pathway could offer a rapid route to approval. Registrational pathway number two evaluates NDV-01 as an adjuvant therapy following TURBT in patients with intermediate-risk NMIBC. We estimate approximately 75,000 patients per year in the U.S. fall into this setting. Since no approved treatments exist in this setting, the study is designed as an open-label randomized controlled trial comparing NDV-01 versus observation. The primary endpoint is disease-free survival. Secondary endpoints include high-grade recurrence-free survival, progression-free survival, and quality-of-life endpoints. We see this as a very attractive opportunity to incorporate NDV-01 into patient care after TURBT and pave the way for broader adoption. Let me share our thinking on how NDV-01 might work in the real-world practice of a urologist. NDV-01 is formulated to create a soft matrix in the bladder, enhancing local urothelial exposure while minimizing systemic toxicity. It can be delivered in the office by a nurse or licensed practical nurse in under five minutes and does not require specialized pharmacy or a hood. This streamlined administration model offers a level of convenience and time savings that differentiates NDV-01 from other agents. As I hand the call over to our CFO, Maged S. Shenouda, I want to emphasize why we are so excited about NDV-01. Our Phase II data gives us high confidence in the rescue program. We believe NDV-01 addresses a clear unmet need with a unique sustained-delivery platform and has the potential to redefine the standard of care in bladder cancer. Maged?

Maged S. Shenouda, CFO

Sure. Thanks, Raj, and good afternoon, everyone. Today, I will spend a few minutes on cipranolone and then provide you with an overview of our first quarter 2026 financial results. Cipranolone is a novel neurosteroid that modulates GABA, one of the most important neurotransmitters. Cipranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of GABAA receptors and alleviate repetitive symptoms and compulsivity disorders. These disorders affect millions of people around the world and include obsessive-compulsive disorder, Tourette syndrome, and Prader-Willi syndrome. We plan to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Our immediate preparations are focused on engaging with the FDA regarding our proposed trial design and putting a robust supply chain in place. Moving now to our financial results. As noted earlier by Brian, this afternoon, Relmada issued a press release announcing our business and financial results for the first quarter ended 03/31/2026. During this call, I will provide a high-level review of our financial results and refer you to our press release and Form 10-Q filing issued this afternoon with more detailed information. Starting with our cash balance, Relmada closed the first quarter 2026 with a cash balance of $234 million compared to $94 million at 12/31/2025. Our first quarter cash balance includes net proceeds of approximately $150 million from a private financing announced 03/09/2026. We expect our current cash resources to provide sufficient runway to fund company operations through 2029, including completion of the Phase III rescue program for NDV-01. Moving briefly through our first quarter financial results: research and development expense for the three months ended 03/31/2026 totaled $8.1 million compared to $12 million for the three months ended 03/31/2025, a decrease of $3.9 million. The decrease was primarily attributable to nonrecurring costs associated with the acquisitions and the license agreement of NDV-01 in 2025. This 2026 decrease was partially offset by increased costs related to the startup of the Phase 3 NDV-01 trials and the Phase 2b cipranolone study and additional R&D personnel. General and administrative expense for the three months ended 03/31/2026 was $11.4 million compared to $6.3 million for the three months ended 03/31/2025, an increase of approximately $5.1 million. The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock-based compensation costs. Net cash used in operating activities for the three months ended 03/31/2026 totaled $15.1 million compared to $18.1 million for the same period in 2025. The net loss for the three months ended 03/31/2026 was $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million, or $0.58 per basic and diluted share, for the three months ended 03/31/2025. Before we open the call for questions, I will turn back to Sergio for some closing remarks. Sergio?

Sergio Traversa, CEO

Thank you, Maged. In closing, I am very confident and optimistic about our clinical programs and the long-term prospects for Relmada. As we are getting ready to initiate the rescue registrational program for NDV-01 in mid-2026, we are focused on execution and look forward to updating you on our progress in the coming quarters. Operator, I would like now to open the call for questions.

Operator, Operator

Yes, sir. Thank you. As a reminder, if you would like to ask a question, please press one on your telephone keypad. Thank you for waiting. We now have our first question, and this comes from Kelsey Goodwin from Piper Sandler. Your line is now open. Please go ahead.

Kelsey Goodwin, Analyst - Piper Sandler

Oh, hey. Thanks for taking my questions, and looking forward to seeing the data this weekend at AUA. I guess a couple from me, if you don't mind. First, for AUA this weekend, it seems like there is some additional Gemdosi literature — I guess how should we think about the growing literature on gemcitabine and the degree of read-through to NDV-01? And then secondly, maybe just updated thoughts on how we should think about this first look at the BCG-unresponsive second-line data later in the year, maybe how many patients we might see or how to benchmark that. And I will leave it at that. Thank you so much.

Sergio Traversa, CEO

Thank you, Kelsey. Sergio here, and good afternoon. Maybe I can take a little bit on the first question. Conventional Gemdosi data is always viewed as a positive because it consolidates how the urologic community believes that this is an effective way to treat bladder cancer. With that said, I will let Raj expand and answer your second question.

Raj S. Pruthi, MD, CMO, Urology

Yeah. Thanks for the question, Kelsey. I am excited as a urologic oncologist to see the number of non-muscle invasive bladder cancer presentations at the AUA this year. And you are right, there is a significant number of Gemdosi papers being presented, increasingly on the efficacy of Gemdosi, especially in the high-risk patient population. Another notable point is the time-toxicity associated with conventional sequential Gemdosi — the burden to the patient and to the provider. I think that tees us up to address that time toxicity with our sustained-release formulation. Regarding your second question about Cohort 2A for the second-line BCG-unresponsive population: my hope is that as we get the study going, we will have a handful of patients, maybe by the end of this calendar year, for whom we can share three-month data. This is an open-label study, so a three-month response and safety rate data by the end of this year or early next year is feasible, and we anticipate a cadence of every three months sharing that data into 2027. I think that answers both of your questions.

Sergio Traversa, CEO

Perfect. Thank you so much. Thank you, Kelsey.

Operator, Operator

Thank you. And the next question comes from Christopher Lu from Lucid Capital Markets. Thank you.

Christopher Lu, Analyst - Lucid Capital Markets

And congrats on the progress you guys have been making so far. So for my question, I was just wondering what your updated thoughts are going into this AUA update in terms of what would be a positive readout for you guys at this 12-month mark, in your opinion?

Sergio Traversa, CEO

Thank you, Chris. Sergio here. I will let Raj, the AUA expert, answer this one.

Raj S. Pruthi, MD, CMO, Urology

Yeah. I think I would really hone in on the BCG-unresponsive population, which is the most difficult to treat after failing BCG. For our BCG-unresponsive group, we see numbers around an 80% landmark and 84% Kaplan-Meier estimates at the 12-month standpoint, which I think is best-in-class. Approved agents for BCG-unresponsive CIS are around 45% at best in many cases, and some have seen numbers up towards 70%. But the numbers of 80–85% that we have are really best-in-class at that point, particularly when coupled with a good safety profile. Chris, I think that 80% number is what I would look at.

Sergio Traversa, CEO

I appreciate the color. Thank you.

Operator, Operator

And the next question comes from Uy Sieng Ear from Mizuho.

Uy Sieng Ear, Analyst - Mizuho

Congrats on all the progress you have made. Maybe just help us to understand a little bit more about your patent estate. So you filed the provisional patent and I am not sure I quite understand the phrase 'if approved, patents claiming priority to the provisional patent would have extended patent life, I guess, into 2047.' Could you maybe just help clarify what that means exactly? And also, with the extended patent term, which is quite extensive, how are you perhaps thinking about doing additional clinical trials — does it give you greater chance of doing combination studies after the rescue programs are done?

Sergio Traversa, CEO

Good afternoon, Uy. It is Sergio here. I will take the first part on the IP and then let Raj handle the development question. We just filed a provisional patent a few weeks ago, so allow me to be not too specific on what the claims are. But in general, these are new patents and reflect the work that has been done in the U.S. in the formulation and manufacturing. It is a new patent that we filed in the U.S., and then we will have the opportunity to file outside the U.S. within the usual one-year window. These are new patents, so they will provide coverage if granted, of course, until sometime in 2047. Regarding prosecution timelines, it is always a guess. We just filed, so from my experience, I would not expect anything in the first 12 months; the patent office is very busy. I would not focus on any response before at least one year.

Raj S. Pruthi, MD, CMO, Urology

And Uy, I can jump in on your other question about where else we might look with NDV-01. I think there are a lot of opportunities, and we can follow the path of where Gemdosi has been effective. We started with BCG-unresponsive disease and are extending into intermediate-risk disease, which represents a significant clinical and market opportunity for Relmada. Another potential opportunity is the high-risk BCG-naive population, which is a large patient population. I think on the heels of the Bridge study, which completed enrollment in August 2025 and is event-driven and will take a couple of years to read out, that is another place where NDV-01 could be relevant. If Bridge reads out and Gemdosi is shown to be noninferior to BCG and becomes an alternative, NDV-01 could step in as an easier-to-use, less burdensome approach for Gemdosi in the BCG-naive high-risk population. Great question.

Sergio Traversa, CEO

Thank you. Thanks, Uy.

Operator, Operator

Thank you. Once again, for those who want to ask a question, please press one on your telephone keypad. The next question comes from Farzin Haq from Jefferies. Your line is now open. Please go ahead.

Farzin Haq, Analyst - Jefferies

Good afternoon, and thank you for taking my question. Following up on an earlier question, you have broad inclusion criteria for Phase 3 in the BCG-unresponsive setting and you are allowing up to two prior lines, including a wide range like TAR-200, Anktiva, etcetera. How are you modeling the potential for variability or dilution of efficacy? And could you adjust to one prior line as the trial progresses?

Sergio Traversa, CEO

Thank you for this. Raj, would you mind taking this?

Raj S. Pruthi, MD, CMO, Urology

Yeah, my pleasure. Thanks for the question, Farzin — a very thoughtful question. We have built guardrails into the study to allow up to two prior first-line therapies. The idea is that beyond that there may be additional resistance mechanisms, and we will evaluate and break down outcomes by one or two prior lines of therapy. We are looking at that. Because these are open-label studies, we can see how these patients are doing in real time. We will also look carefully at patients who have had prior intravesical chemotherapy as part of their BCG-unresponsive disease, particularly prior Anktiva and prior gemcitabine-containing approaches. We are excluding prior Gemdosi in these patients because we are giving a Gemdosi treatment. But we will consider intravesical gemcitabine and other prior agents. In my practice, using a Gemdosi rescue is appropriate in some circumstances, so we will look at both. Our approach is to define what the appropriate second-line therapy is. These therapies will be sequenced by urologists several times before cystectomy. Right now, there are many agents approved or in development for first-line, but very few in second-line. That gives us an opportunity to provide high levels of evidence and a label for the second-line approach. Once urologists use it there, they could use it before or after other therapies in practice, but we are mindful of lines of therapy and of the specific prior therapies patients have received.

Sergio Traversa, CEO

Thanks for the question, Farzin.

Farzin Haq, Analyst - Jefferies

And then on your Phase 3 primary endpoint, does FDA's acceptance of CR at any time imply any durable responses? For example, median duration of response greater than six months?

Raj S. Pruthi, MD, CMO, Urology

So their phrasing was that they want the primary endpoint to be CR at any time, and they also want to see duration of response. The wording they used is that they want the totality of the data. So I think they are getting at what you are asking: a strong CR at any time — for example, at three months — is valuable, but they want to see some level of durability as well. They did not give a specific numerical threshold for that, but they want to see durability expressed as duration of response alongside CR at any time. Given there are few agents approved in this space, the FDA will consider the totality of the data when evaluating benefit, and the alternative for these patients often remains radical cystectomy.

Farzin Haq, Analyst - Jefferies

And then a quick one: what is the expectation for enrollment cadence across both pivotal studies? Can the in-office profile serve as a recruitment advantage potentially?

Raj S. Pruthi, MD, CMO, Urology

Yeah, great question. Having been on a number of site qualification visits, investigator enthusiasm is significant. Many of the sites participating to address cohort one, the intermediate-risk study, participated in PIVOT-006 and are excited for the next intermediate-risk study. We have modeled enrollment timelines out to 15 to 18 months for certain cohorts, but with investigator enthusiasm and the precedent set by groups like SWOG for recruitment, I feel confident we will be able to meet or exceed that timeline. Regarding the second-line therapy, we are anticipating approximately 12 months for enrollment, but again that is dependent on site activation. There is also incredible enthusiasm because urologists currently have very limited options for these patients. With some approved first-line therapies showing 12-month CR rates in the range of 19% to 45%, meaning that 55% to 80% of patients recur within one year after first-line therapy, there is a large population of BCG-unresponsive CIS patients who have failed first-line therapy. We are not competing with other studies in many of these centers for these patients, so I am optimistic we will be able to meet the 12-month enrollment timeline for the second-line cohort.

Sergio Traversa, CEO

Great. Super helpful. Thank you, Raj. Thanks, Farzin.

Operator, Operator

Thank you. And there are no further questions that came through. This concludes our question-and-answer session and the call for today. Thank you, everyone. You may now disconnect.